Upcoming FDA Hearing on Abuse of Cough and Cold Medications Misses the Mark

/PRNewswire/ -- The Center for Medicine in the Public Interest released the results of a national Teen Substance Abuse survey today, indicating that police officers and high school teachers nationwide believe alcohol and marijuana are the most serious problem substances facing teenagers. These survey results come as the Food and Drug Administration has scheduled an Advisory Committee meeting for September 14 to examine whether abuse of cough and cold medications by teens requires stricter controls on the sale of those commonly used products.

Police and teachers polled do not believe it is a good idea to force Americans to visit a doctor to get a prescription to purchase commonly sold cough and cold medicines. However, an FDA Advisory Committee next week could decide to make more than 100 brand name, over-the-counter cold and cough medicines containing the ingredient dextromethorphan available only through a doctor's prescription or place them behind the counter at pharmacies, forcing customers to receive assistance from a pharmacist or store employee to get the medicines.

When asked which substances pose the greatest negative impact on teens, teachers and police overwhelmingly identified marijuana and alcohol, followed by methamphetamine and cocaine. Additionally, no police and only 1% of high school teachers cited cough and cold medicines as having the greatest negative impact on teens.

When you think of substance abuse,
   which substances do you see as
   having the greatest negative impact
   on teens?                           Police      H.S. Teachers
  ------------------------------------ ------      -------------
  Alcohol//beer                                51%              70%
  -------------                               ---              ---
  Marijuana//pot                               69%              51%
  Prescription drugs//prescription
   pills                                       27%              15%
  --------------------------------            ---              ---
  Methamphetamine//crystal
   methamphetamine                             28%               9%
  Cocaine//coke//crack                         22%               8%
  --------------------                        ---              ---
  Heroin                                       12%               3%
  Ecstasy                                       6%               5%
  -------                                     ---              ---
  Cigarettes//tobacco                           3%               6%
  Inhalants//spray can fumes                    3%               -
  --------------------------                  ---              ---
  Over the counter medicine//non
   prescription medication                      1%               2%
  Cough//Medicines//Cold
   Medicines//DXM                               -                1%

CMPI's study also shows that alcohol, marijuana, prescription drugs, methamphetamine, cocaine and cigarettes are cited among the top substances posing the most serious problems to teens:

% Selecting as Most/2(nd) Most/
   3(rd) Most Serious Problem
   Substance                          Police      H.S. Teachers
  ----------------------------------- ------      -------------
  Alcohol                                     82%              88%
  -------                                    ---              ---
  Pot                                         76%              75%
  ---                                        ---              ---
  Prescription drugs                          41%              27%
  ------------------                         ---              ---
  Meth                                        32%              22%
  ----                                       ---              ---
  Cigarettes                                  14%              36%
  ----------                                 ---              ---
  Cocaine/Crack                               27%              15%
  -------------                              ---              ---
  Ecstasy                                      5%               9%
  -------                                    ---              ---
  OTC cough and cold medicine                  5%               8%

The survey also reveals that by a margin of two to one, police officers and high school teachers support education efforts as a means to address abuse of over-the-counter cough and cold medicines, versus restricted accessibility to consumers.

"Americans expect to be able to buy cough medicines conveniently at the supermarket or their neighborhood corner store," says CMPI Vice President Robert Goldberg, Ph.D. "Overly restricting access to cough and cold products containing dextromethorphan will create more health problems than it will solve, especially during cold and flu seasons. We need to find common sense solutions and invest more resources in education."

The entire Teen Substance Abuse survey is available at www.cmpi.org and the poll was conducted by Fabrizio Ward and Associates.

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Co-Payment Increases Result in Gaps in Veterans' Prescription Usage

TT Note: It just doesn't seem right that our men and women who fought for our country should have to choose whether or not to take medicine.

/PRNewswire-USNewswire/ -- Fewer veterans filled their prescriptions for cholesterol-lowering drugs after an increase in co-payment costs for prescription drugs, researchers report in Circulation: Journal of the American Heart Association.

In February 2002, the Veterans Administration (VA) increased prescription co-payments from $2 to $7 per 30-day drug supply.

To determine the impact of the co-payment increase on cholesterol-lowering medication adherence, researchers examined the electronic records of 5,604 veterans treated at the Philadelphia Veterans Administration (VA) Medical Center from November 1999 to April 2004.

They compared veterans in the all co-payment group and the some co-payment group with veterans who were exempt from making prescription drug co-payments. The all co-payment group paid co-pays for all drugs and the some co-payment group paid co-pays only for drugs for non-service connected health problems with out-of-pocket expenses capped at $840 per year.

Researchers analyzed the differences in cholesterol-lowering medication adherence during the 24 months before and 24 months after the institution of co-payments. Evidence of veterans having cholesterol-lowering medication 80 percent or more of the time were considered adherent.

Researchers found:
-- The number of patients who had medications available for more than 80
percent of the time declined by more than 19 percent in both the all
co-payment group and the some co-payment group. In comparison,
veterans exempt from co-payments, used as controls in the study, had a
decline of 12 percent.
-- The odds of having a continuous gap without medications for more than
90 days was three times higher among patients in the all co-payment
group and twice as high in patients in the some co-payment group when
compared to the exempt group.


"The increase in co-payments adversely impacted lipid-lowering medication adherence among veterans," said Jalpa A. Doshi, Ph.D., lead author of the study and research assistant professor of medicine at the University of Pennsylvania School of Medicine. "Of even greater concern is our finding on the similar adverse effect of the co-payment increase in veterans who are at higher risk for coronary artery disease taking the medications for primary or secondary prevention."

Statins and other cholesterol-lowering drugs have been shown to reduce the risk of future coronary events and cardiovascular mortality in patients at high risk, Doshi said.

"It is concerning to see that the increase in co-payments adversely affected the use of these usually long-term medications, especially since the prevalence of heart disease is higher in the VA population than in the general population," Doshi said. "These weren't just short gaps interspersed between lipid-lowering medication refills, but continuous gaps for 90 days or more."

The study did not look at the possible increase in use of medical care due to the lack of cholesterol-lowering drugs. Other studies have shown that not taking medications for chronic diseases increases healthcare costs.

"Policymakers need to realize that the one-size-fits-all approach in designing cost-sharing policies can adversely impact high-risk patient groups," Doshi said. "This seemingly small increase from $2 to $7 more than tripled the out-of-pocket costs for veterans, who were more likely to have a lower income than the patients in the private sector."

The VA should at least consider charging lower co-payments for generic drugs than for the brand-name prescription drugs, Doshi said. "Right now the VA charges a flat co-payment for a 30-day prescription, whether it is generic or a brand-name drug. This is particularly relevant in the case of lipid-lowering drugs such as statins, wherein two brand drugs became available as generics in 2006 and are available at significantly lower prices."

She said a more-promising approach is a "value-based insurance design" method that would link co-payments to the patient's need with lower co-payments for drugs with higher expected therapeutic benefit and higher co-payments for drugs with lower therapeutic benefit.

The co-payment was increased from $7 to $8 in 2006, and with present budget constraints, it's likely that the co-payment will be further increased, Doshi said.

The VA Center for Health Equity, Research and Promotion (CHERP), American Heart Association Pharmaceutical Roundtable Award, Commonwealth of Pennsylvania, the National Institute of Aging and the Penn Institute on Aging funded the study.

Co-authors are: Jingsan Zhu, M.B.A.; Bruce Lee, M.D., M.B.A.; Stephen Kimmel, M.D., M.S.C.E.; and Kevin Volpp, M.D., Ph.D. Individual author disclosures are available on the manuscript.

Statements and conclusions of study authors that are published in American Heart Association scientific journals are solely those of the study authors and do not necessarily reflect the association's policy or position. The association makes no representation or guarantee as to their accuracy or reliability. The association receives funding primarily from individuals, foundations and corporations (including pharmaceutical, device manufacturers and other companies) also make donations and fund specific association programs and events. The association has strict policies to prevent these relationships from influencing the science content. Revenues from pharmaceutical and device corporations are available at www.americanheart.org/corporatefunding.

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